- It took slightly more than a year of regulatory review, but Jazz Pharmaceuticals received Wednesday approval for a drug designed to improve wakefulness in cases of excessive daytime sleepiness.
- Solriamfetol's regulatory OK, tailored to adults with either narcolepsy or obstructive sleep apnea, came after a three-month review extension last December by the Food and Drug Administration. But multiple Wall Street analysts noted the delay appears to have been worth it, as the medicine avoided a black box warning on its label.
- Jazz executives requested the agency consider 150 mg as the highest dose for approval last December, leading to the review extension, according to analysts. Data from the 300 mg treatment showed higher rates of side effects, which may have resulted in a black box warning.
As Evercore ISI's Umer Raffat wrote in a March 21 note to investors, the key part of this approval is what's not in the label: an approval for the higher 300 mg dose level.
Oddly enough, that's a good thing, Raffat noted. The analyst said its absence helped produce a clean prescription label for solriamfetol, which will be marketed as Sunosi. The FDA's label still included 300 mg data, but notes the agency did not approve the medicine at that strength.
"Dosages above 150 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions," Sunosi's label states.
Analysts from SVB Leerink and Cowen & Co. both pegged peak annual sales surpassing $500 million for Sunosi. Cowen's Ken Cacciatore argued its efficacy bests Provigil (modafinil) and Nuvigil (armodafinil), which have been on the market for years.
In a survey of 25 sleep physicians, Cacciatore reported that roughly 70% of the doctors agreed most patients with excessive daytime sleepiness lack a sufficient treatment option, and more than half of all patients fail over time on Provigil or Nuvigil.
Even excluding the 300 mg dose level, though, Sunosi still brings side effects. The most common were headache, nausea, decreased appetite and anxiety.
The company plans to hire 50 more staff to add to its existing sleep salesforce of 95 people, which will now cover Sunosi and Xyrem (sodium oxybate). Xyrem is the company's top-selling product, with its $1.4 billion in 2018 sales making up three-quarters of Jazz's total product sales.
Jazz will still have to wait until the Drug Enforcement Administration makes a scheduling decision on Sunosi. The company noted this typically takes about three months, which would put the drug on track for a launch in mid-2019. Analysts also expect a pricing decision around that time as well.
The biopharma is waiting on a European regulatory decision, which could come by the end of 2019. The company submitted for approval with the European Medicines Agency in the fourth quarter of 2018.
The company's stock opened up 2% Thursday, with share prices climbing to nearly $137 apiece.